Effects of oral administration of ivabradine (7.5 mg bid) on post-ischaemic stunning induced by exercise stress in patients with coronary artery disease and exercise inducible ischaemia.
- Conditions
- Coronary artery diseaseMedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000783-98-IT
- Lead Sponsor
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Aged 30 to 75 years - Male or female - Evidence of coronary artery disease proven by clinical history - Sinus rythm and resting heart rate equal or higher than 70 bpm
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- Patient with unstable angina - Contra-indication to the administration of ivabradine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effects of Ivabradine on post-ischaemic stunning induced by exercise stress in patients with stable coronary artery disease and exercise-inducible ischaemia;Secondary Objective: To investigate the effect of ivabradine on: - arterial elastance, - ventricular arterial coupling, - safety;Primary end point(s): Measurement of the myocardial stunning;Timepoint(s) of evaluation of this end point: Myocardial stunning measured at each visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Arterial elastance - Ventricular arterial coupling - Safety;Timepoint(s) of evaluation of this end point: Measured at each visit